Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial

NCT ID: NCT03077854

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2023-05-31

Brief Summary

Thoracic radiotherapy (TRT) is a standard curative treatment for locally advanced, unresectable non-small cell lung cancer (NSCLC) and limited stage small cell lung cancer (SCLC). TRT has been recognized to cause moderate to severe lung injury in a substantial portion of patients. Conventional standard curative TRT planning techniques minimize the radiation dose to the anatomical lungs, without adaption of regional pulmonary function variations. The principal investigator hypothesized that preferential avoidance of functional lung during curative TRT may decrease the risk of pulmonary toxicity. Functional lung regions are identified using four- dimensional computed tomography for ventilation imaging. This randomized, single-blind trial will comprehensively assess the impact of functional lung avoidance on pulmonary toxicity, quality of life, and clinical outcome in patients receiving curative TRT for locally advanced NSCLC and SCLC.

Conditions

Small Cell Lung Cancer, Limited Stage; Stage III Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Functional Lung Avoidance-TRT

Functional Lung Avoidance Thoracic Radiotherapy

The avoidance thoracic radiotherapy treatment plan will be designed to optimize such that radiation dose to functional lung identified by four-dimensional (4D) CT ventilation imaging is as low as reasonably achievable

Group Type: EXPERIMENTAL

Functional Lung Avoidance Thoracic Radiotherapy

Intervention Type: RADIATION

• Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed)
• Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed)
• Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions

Standard-TRT

Standard Thoracic Radiotherapy

The standard thoracic radiotherapy treatment plan will be designed without reference to the functional lung 4D CT ventilation imaging

Group Type: ACTIVE_COMPARATOR

Standard Thoracic Radiotherapy

Intervention Type: RADIATION

• Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed)
• Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed)
• Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions

Interventions

Functional Lung Avoidance Thoracic Radiotherapy

• Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed)
• Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed)
• Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions

Intervention Type: RADIATION

Standard Thoracic Radiotherapy

• Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed)
• Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed)
• Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Patients with a histologic diagnosis of non-small cell carcinoma or small cell carcinoma of lung

2. Locally advanced stage III A or III B lung carcinoma according to American Joint Committee on Cancer (AJCC) 7th edition or highly selected patients with oligo-metastatic disease amendable for thoracic radiotherapy with curative intent

3. Not undergoing radical surgical resection

4. Patients do not have prior radiotherapy to the thorax

5. Age ≥ 20 years

6. Karnofsky performance status (KPS) ≥ 60%.

7. Women of childbearing potential and male participants must practice adequate contraception

8. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent

Exclusion Criteria

1. Prior radiotherapy to thorax

2. Unable to receive assigned radiation dose due to normal lung constraint

3. Inability to attend full course of radiotherapy or follow-up visits

4. Presence of metastatic disease. Patients who present with oligo-metastatic disease where all metastases have been ablated (with surgery or radiotherapy) or in complete remission after systemic therapy are candidates if they are receiving radiotherapy to the thoracic disease with curative intent

5. Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:

• Uncontrolled active infection requiring intravenous antibiotics at the time of registration
• Transmural myocardial infarction ≤ 6 months prior to registration.
• Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration.
• Life-threatening uncontrolled clinically significant cardiac arrhythmias.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
• Uncontrolled psychiatric disorder.

6. Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic.

7. Pregnant or lactating women

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feng-Ming Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Feng-Ming Hsu, MD

Role: CONTACT

hsufengming@ntuh.gov.tw

+886-2-23123456 ext. 67061

Facility Contacts

Feng-Ming Hsu, MD

Role: primary

hsufengming@ntuh.gov.tw

+886-2-23123456 ext. 67061

Other Identifiers

201604007RINA

Identifier Type: -

Identifier Source: org_study_id